Actively Recruiting
Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Led by Kyowa Kirin Co., Ltd. · Updated on 2025-11-18
72
Participants Needed
10
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the first in human study of KK2845. This trial consists of Part 1 (Dose escalation) and Part 2 (Backfill). In Part 1, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2845 in patients with relapsed or refractory acute myeloid leukemia. Part 2 will collect additional data at tolerated doses of KK2845.
CONDITIONS
Official Title
Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide voluntary written consent to participate.
- Age 18 years or older at consent.
- Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO 2022 classification.
- Diagnosis of relapsed or refractory AML as defined by specific relapse or treatment failure criteria.
- No standard treatment options with sustained remission or have refused standard treatment.
- ECOG performance status between 0 and 2.
- Adequate hematopoietic, liver, kidney, and cardiac function within specified laboratory limits.
- Expected survival of more than 3 months.
- Agreement to use effective contraception from consent until specified times after treatment for men and women of child-bearing potential.
- Negative pregnancy test for women of child-bearing potential before first dose.
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APML).
- Suspected extramedullary disease.
- History of other active malignancies except certain treated cancers.
- White blood cell count above 25000/mm3 unless controlled with hydroxyurea.
- Previous allogeneic hematopoietic stem cell transplant unless criteria for time and graft-versus-host disease are met.
- Recent anticancer therapy, radiation, unapproved devices, investigational drugs, or major surgery within specified time frames.
- Receipt of live vaccine within 4 weeks prior to treatment.
- Infections requiring systemic treatment or suspected COVID-19 infection.
- Active interstitial lung disease or history thereof.
- Recent use of systemic steroids or immunosuppressants except low-dose or topical forms.
- History of severe cardiovascular or arterial thrombotic events within 6 months.
- Positive tests for certain viral infections unless meeting specific conditions.
- Immunodeficiency or history of severe allergic reactions to antibody drugs.
- Pregnancy, lactation, or intent to become pregnant.
- Psychiatric or social conditions hindering trial compliance.
- Other conditions deemed unsuitable by investigators.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Actively Recruiting
2
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
3
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
4
Kanazawa University Hospital
Kanazawa, Japan, 920-8641
Actively Recruiting
5
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
6
Kindai University Hospital
Osaka, Japan, 589-8511
Actively Recruiting
7
Saitama Medical University Hospital
Saitama, Japan, 350-0495
Actively Recruiting
8
Toranomon Hospital
Tokyo, Japan, 105-8470
Actively Recruiting
9
Juntendo University Hospital
Tokyo, Japan, 113-8431
Actively Recruiting
10
Nippon Medical School Hospital
Tokyo, Japan, 113-8603
Actively Recruiting
Research Team
M
Masayoshi Noshiro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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